While the vaccine studies for COVID-19 have caused an increased interest among the media about how clinical trials are performed and their legal and ethical ramifications, they've always been common. Clinical trials are how providers and pharmaceutical manufacturers test drugs or determine how to best treat conditions.
Participating in a clinical trial can be risky. Depending on the phase, the people enrolled in a clinical trial may be among the first few thousand patients to take a medication — at this point, many side effects are still unknown. In order to enroll, participants release the trial sponsors of much of their liability regarding adverse effects.
However, this doesn't mean that medical malpractice is impossible — clinical trials still need to be conducted in a manner that avoids undue harm to participants. If you've suffered an injury as part of a clinical trial, you may be wondering if you have a legal case against the sponsors running it. Below, you'll find some examples where you may have grounds to contact an attorney because of medical malpractice.
1. Gross Negligence
While rare during clinical trials, gross negligence is always grounds for a medical malpractice suit. Gross negligence refers to obvious medical errors that result in bodily injury. For example, a nurse or physician administering the trial's medication may accidentally give you a dose that's too high or give it through the wrong route of administration (for example, intravenously instead of intramuscularly.) If their error results in harm, then they may be considered liable for malpractice.
2. Lack of Informed Consent to All Risks
When you sign up for a clinical trial, you'll fill out a considerable amount of paperwork. Part of this is the informed consent form you'll sign, which details all of the known risks of the medication you're taking. Your signature on this form indicates that you accept all of these risks. As a clinical trial participant, your informed consent form will also indicate that you accept currently unknown risks.
However, it may be the case that the trial sponsors know about risks that aren't included in the informed consent form. Side effects may have been discovered in prior phases that aren't disclosed on the form. If you experience injury from side effects during the trial and weren't warned about them in the informed consent form, then you may want to contact a medical malpractice attorney. If the trial sponsors knew about side effects without disclosing them, they may have been legally negligent.
3. Failure to Monitor
All medical providers have a duty to monitor patients under their care. Clinical trials are no exception. If you experience adverse side effects during the clinical trial, the trial sponsors can't simply brush them under the rug — the trial physician needs to follow up on them, which may include further diagnostic testing along with treating the side effects. Ignoring side effects during the trial may be considered medical negligence on the part of the trial sponsors.
Overall, medical malpractice lawsuits over clinical trials are rare. Participants do accept increased risk as a part of enrolling in the trial. However, this doesn't free providers from their ethical and legal duty to avoid harm to patients. If you believe that you have been harmed as a result of medical negligence during a clinical trial, contact medical malpractice attorneys, such as Bennett Bigelow & Leedom PS, in your area — depending on the circumstances, you may be able to receive compensation for the injuries you sustained.